NCT01418677

An Open-Label Study to Assess the Pharmacokinetics and Safety of HALAVEN in Subjects With Cancer Who Also Have Impaired Renal Function

An Open-Label Phase 1 Study to Assess the Pharmacokinetics and Safety of HALAVEN in Subjects With Cancer Who Also Have Impaired Renal Function

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 19 (actual)
• Sponsor: Eisai Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is an open-label non-randomized study in subjects with advanced or metastatic solid tumors who are no longer responding to available therapy. HALAVEN will be administered to subjects on Days 1 and 8 of a 21-day cycle.

Conditions

• Unspecified Adult Solid Tumor, Protocol Specific

Interventions

Type	Name	Description
DRUG	E7389	Severe renal impairment-the dose to be administered will be based on the interim analyses of safety and pharmacokinetics in subjects with moderate renal impairment (Cohort 1).
DRUG	E7389	Moderate renal impairment-HALAVEN will be dosed at 1.4 mg/m2.
DRUG	E7389	Normal renal function-HALAVEN will be dosed at 1.4 mg/m2.

Timeline

• Start date: 2011-10-01
• Primary completion: 2014-07-01
• Completion: 2015-05-01
• First posted: 2011-08-17
• Last updated: 2016-05-17

Locations

9 sites across 1 country: United States